CancerGBCPRT0009NCT02239575
Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples
An observational study of Cancer, run by Global BioClinical at 1 site in United States.
Trial summary
This study will enroll specimens from subjects diagnosed with various cancers and who have either: 1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 27 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surplus surgical specimens from subjects diagnosed with cancer
Who may be able to join
- Any adult age
- Any sex
- Able to provide consent for surplus tissue and/or blood donation
- Diagnosed with one of the cancer indications listed below:
- Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
- Have not yet received treatment for cancer
Who cannot join
- Not diagnosed with required cancer indication
- Not scheduled to undergo surgical resection of the tumor
- Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
- Not able to donate an adequate volume of blood to meet minimum requirements
Trial locations and contacts
1 site in 1 country.
About this study
This study will enroll specimens from subjects diagnosed with various cancers and who have either:
- RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks no longer required to be maintained on file - discard blocks, or
- PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected.
Subject clinical information will be collected, including basic demographic information, medical history, current cancer history and treatment. A final pathology report will be obtained for each subject's surgical specimen. In some instances, and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
Read the detailed description
CANCER INDICATIONS:
Bladder Cancer - Urothelial carcinoma - nonpapillary Bladder Cancer - Urothelial carcinoma - papillary Brain Cancer - Astrocytoma Brain Cancer - Glioblastoma Brain Cancer - Medulloblastoma Breast Cancer - Ductal Carcinoma Breast Cancer - Lobular Carcinoma Cervical Cancer - Squamous Cell Carcinoma Colorectal Cancer - Adenocarcinoma Esophageal Cancer - Adenocarcinoma Gastric Cancer Head and Neck Cancer - Squamous Cell Carcinoma Hematologic Cancer - Acute Lymphocytic Leukemia (ALL) Hematologic Cancer - Acute Myeloid Leukemia (AML) Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) Hematologic Cancer - Diffuse Large B-cell Lymphoma Hematologic Cancer - Multiple Myeloma (MM) Hematologic Cancer - Non-Hodgkins Lymphoma (NHL) Kidney Cancer - Papillary Carcinoma Kidney Cancer - Renal cell Carcinoma Liver Cancer - Hepatocellular Carcinoma Lung Cancer - Adenocarcinoma Lung Cancer - Squamous Cell Cancer Melanoma Pancreatic Cancer - Ductal Adenocarcinoma Prostate Cancer - Adenocarcinoma Sarcomas Thyroid Cancer - Follicular Carcinoma Thyroid Cancer - Papillary Carcinoma Uterine Cancer - Endometrial Carcinoma
- Conditions
- Cancer
- Keywords
- Assorted cancers (oncology)
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples
This study will identify novel cancer biomarkers associated with various solid tumor sub-types, tumor stages, and from patients with various responses to treatment.
Measured: Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startMar 2014
- Primary completion31 Dec 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global BioClinical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Mucci, Study director, GBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239575
- Sponsor's protocol ID
- GBC PRT0009
- Acronym
- GBCPRT0009
- Status last verified
- Feb 2023
- First submitted
- 16 Jul 2014
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples
- ClinicalTrials.gov ID
- NCT02239575
- Acronym / sponsor ID
- GBCPRT0009 / GBC PRT0009
- Conditions
- Cancer
- Keywords
- Assorted cancers (oncology)
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Global BioClinicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll specimens from subjects diagnosed with various cancers and who have either:
- RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks no longer required to be maintained on file - discard blocks, or
- PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected.
Subject clinical information will be collected, including basic demographic information, medical history, current cancer history and treatment. A final pathology report will be obtained for each subject's surgical specimen. In some instances, and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
Detailed description
CANCER INDICATIONS:
Bladder Cancer - Urothelial carcinoma - nonpapillary Bladder Cancer - Urothelial carcinoma - papillary Brain Cancer - Astrocytoma Brain Cancer - Glioblastoma Brain Cancer - Medulloblastoma Breast Cancer - Ductal Carcinoma Breast Cancer - Lobular Carcinoma Cervical Cancer - Squamous Cell Carcinoma Colorectal Cancer - Adenocarcinoma Esophageal Cancer - Adenocarcinoma Gastric Cancer Head and Neck Cancer - Squamous Cell Carcinoma Hematologic Cancer - Acute Lymphocytic Leukemia (ALL) Hematologic Cancer - Acute Myeloid Leukemia (AML) Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) Hematologic Cancer - Diffuse Large B-cell Lymphoma Hematologic Cancer - Multiple Myeloma (MM) Hematologic Cancer - Non-Hodgkins Lymphoma (NHL) Kidney Cancer - Papillary Carcinoma Kidney Cancer - Renal cell Carcinoma Liver Cancer - Hepatocellular Carcinoma Lung Cancer - Adenocarcinoma Lung Cancer - Squamous Cell Cancer Melanoma Pancreatic Cancer - Ductal Adenocarcinoma Prostate Cancer - Adenocarcinoma Sarcomas Thyroid Cancer - Follicular Carcinoma Thyroid Cancer - Papillary Carcinoma Uterine Cancer - Endometrial Carcinoma
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surplus surgical specimens from subjects diagnosed with cancer
Key inclusion criteria (6 listed)
- Any adult age
- Any sex
- Able to provide consent for surplus tissue and/or blood donation
- Diagnosed with one of the cancer indications listed below:
- Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
Key exclusion criteria (4 listed)
- Not diagnosed with required cancer indication
- Not scheduled to undergo surgical resection of the tumor
- Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
- Not able to donate an adequate volume of blood to meet minimum requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples
Time frame: Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year
This study will identify novel cancer biomarkers associated with various solid tumor sub-types, tumor stages, and from patients with various responses to treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Mucci study director
GBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Global BioClinical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples (time frame: Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.